Drug Master Files for: fluvastatin sodium
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fluvastatin sodium Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 17879 | I | II | 12/7/2004 | CADILA HEALTHCARE LTD | FLUVASTATIN SODIUM |
| 18493 | A | II | 7/7/2005 | BIOCON LTD | FLUVASTATIN SODIUM AMORPHOUS |
| 18762 | A | II | 9/13/2005 | BIOCON LTD | FLUVASTATIN SODIUM |
| 18911 | A | II | 10/11/2005 | FIS FABBRICA ITALIANA SINTETICI SPA | FLUVASTATIN SODIUM HYDRATE USP |
| 19296 | A | II | 3/24/2006 | TEVA PHARMACEUTICAL INDUSTRIES LTD | FLUVASTATIN SODIUM |
| 20528 | I | II | 5/11/2007 | USV LTD | FLUVASTATIN SODIUM USP |
| 21509 | A | II | 3/31/2008 | LUPIN LTD | FLUVASTATIN SODIUM (MICRONIZED) USP |
| >DMF No. | >Status | >Type | >Submission Date | >Holder | >Subject |
Drug Master File Glossary
STATUS OF DMFS
- A = Active. This means that the DMF was found acceptable for filing, administratively, and is up-to-date.
- I = Inactive
- N = Not an assigned number
- P = DMF Pending Filing Review
TYPES OF DMFs
- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)
- Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
- Type III Packaging Material
- Type IV Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
- Type V FDA Accepted Reference Information
